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LEVETIRACETAM TEVA 100 MG/ML ORAL SOLUTION

Active substance(s): LEVETIRACETAM / LEVETIRACETAM / LEVETIRACETAM

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ZINC Ref:

EBNUK1439b LEA LEVETIRACETAM 100mg/ml SOL TUK Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
420 mm
154 mm
N/A
N/A

Version:

5

23 June 2017

Colours Used:

Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

BLACK

Template

Levetiracetam Teva oral solution also contains
maltitol. If you have been told by your doctor that you
have an intolerance to some sugars, contact your
doctor before taking this medicinal product.

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Read all of this leaflet carefully before you or your
child start taking this medicine because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor
or pharmacist.
- This medicine has been prescribed for you only. Do
not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.

3

How to take Levetiracetam Teva
100 mg/ml Oral Solution

Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Take the oral solution following your doctor’s
instructions.
Levetiracetam Teva must be taken twice a day, once
in the morning and once in the evening, at about the
same time each day.
Monotherapy
Dose in adults and adolescents from 16 years of age:
What is in this leaflet:
Measure the appropriate dosage using the 10 ml
1 What Levetiracetam Teva 100 mg/ml oral solution syringe included in the package for patients 4 years
is and what it is used for
and above.
2 What you need to know before you take
General dose: Levetiracetam Teva is taken twice
Levetiracetam Teva 100 mg/ml oral solution
daily, in two equally divided doses, each individual
3 How to take Levetiracetam Teva 100 mg/ml oral
dose being measured between 5 ml (500 mg) and
solution
15 ml (1500 mg).
4 Possible side effects
When you first start taking Levetiracetam Teva, your
5 How to store Levetiracetam Teva 100mg/ml oral
doctor will prescribe you a lower dose for 2 weeks
solution
before giving you the lowest general dose.
6 Contents of the pack and other information
Add-on therapy
What Levetiracetam Teva 100 mg/ml
in adults and adolescents (12 to 17 years)
1 Oral Solution is and what it is used for Dose
weighing 50 kg or more:
Measure the appropriate dosage using the 10 ml
Levetiracetam Teva 100 mg/ml oral solution is an
syringe included in the package for patients of 4 years
antiepileptic medicine (a medicine used to treat
and above.
seizures in epilepsy).
General dose: Levetiracetam Teva is taken twice daily,
Levetiracetam Teva is used:
in two equally divided doses, each individual dose
• on its own in adults and adolescents from 16 years
being measured between 5 ml (500 mg) and 15 ml
of age with newly diagnosed epilepsy, to treat a
(1500 mg).
certain form of epilepsy. Epilepsy is a condition
Dose in children 6 months and older:
where the patients have repeated fits (seizures).
Levetiracetam is used for the epilepsy form in which Your doctor will prescribe the most appropriate
the fits initially affect only one side of the brain, but pharmaceutical form of Levetiracetam according to
could thereafter extend to larger areas on both sides the age, weight and dose.
For children 6 months to 4 years, measure the
of the brain (partial onset seizure with or without
secondary generalisation). Levetiracetam has been appropriate dosage using the 3 ml syringe included
given to you by your doctor to reduce the number of in the package.
fits.
For children above 4 years, measure the appropriate
dosage using the 10 ml syringe included in the
• as an add-on to other antiepileptic medicines to
package.
treat:
General dose: Levetiracetam Teva is taken twice
- partial onset seizures with or without
daily, in two equally divided doses, each individual
generalisation in adults, adolescents, children
dose being measured between 0.1 ml (10 mg) and 0.3
and infants from one month of age
- myoclonic seizures (short, shock-like jerks of a ml (30 mg), per kg bodyweight of the child. (see table
below for dose examples).
muscle or group of muscles) in adults and
adolescents from 12 years of age with juvenile
Dose in children 6 months and older
myoclonic epilepsy
Weight
Starting dose:
Maximum dose:
- primary generalised tonic-clonic seizures
0.1 ml/kg
0.3 ml/kg
(major fits, including loss of consciousness) in
twice daily
twice daily
adults and adolescents from 12 years of age
with idiopathic generalised epilepsy (the type of
6 kg
0.6 ml twice daily 1.8 ml twice daily
epilepsy that is thought to have a genetic cause).
8 kg
0.8 ml twice daily 2.4 ml twice daily

What you need to know before you take
Levetiracetam Teva 100 mg/ml Oral
Solution

Do not take Levetiracetam Teva
If you are allergic to levetiracetam, pyrrolidone
derivatives or any of the other ingredients of this
medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking this
medicine:
• if you suffer from kidney problems, follow your
doctor’s instructions. He/she may decide if your
dose should be adjusted.
• if you notice any slow down in the growth or
unexpected puberty development of your child,
please contact your doctor.
• a small number of people being treated with
anti-epileptics such as Levetiracetam Teva have
had thoughts of harming or killing themselves. If
you have any symptoms of depression and/or
suicidal ideation, please contact your doctor.
Children and adolescents
• Levetriacetam Teva is not indicated in children and
adolescents below 16 years on its own
(monotherapy).
Other medicines and Levetiracetam Teva
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Do not take macrogol (a drug used as laxative) for one
hour before and one hour after taking levetiracetam
as this may result in a loss of its effect.
Pregnancy and breast-feeding
If you are pregnant or breastfeeding, think you may
be pregnant or are planning to have a baby, ask your
doctor for advice before taking this medicine.
Levetiracetam Teva should not be used during
pregnancy unless clearly necessary. A risk of birth
defects for your unborn child cannot be completely
excluded. Levetiracetam Teva has shown unwanted
reproductive effects in animal studies at dose levels
higher than you would need to control your seizures.
Breast-feeding is not recommended during treatment
Driving and using machines
Levetiracetam Teva may impair your ability to drive
or operate any tools or machinery, as it may make
you feel sleepy. This is more likely at the beginning of
treatment or after an increase in the dose. You should
not drive or use machines until it is established that
your ability to perform such activities is not affected.
Levetiracetam Teva 100 mg/ml oral solution contains
methyl parahydroxybenzoate, propyl
parahydroxybenzoate and maltitol
Levetiracetam Teva oral solution includes methyl
parahydroxybenzoate (E218) and propyl
parahydroxybenzoate (E216) which may cause
allergic reactions (possibly delayed).

REG0093670

EBNUK1439b LEA LEVETIRACETAM 100mg/ml SOL TUK
PANTONE® GREEN C

Levetiracetam Teva 100 mg/ml
Oral Solution

2

ZINC Ref:

10 kg

1 ml twice daily

15 kg

1.5 ml twice daily

4.5 ml twice daily

20 kg

2 ml twice daily

6 ml twice daily

25 kg

2.5 ml twice daily

From 50 kg 5 ml twice daily

3 ml twice daily

7.5 ml twice daily
15 ml twice daily

Dose in infants (1 month to less than 6 months):
For infants 1 month to less than 6 months, measure
the appropriate dosage using the 1 ml syringe
included in the package.
General dose: Levetiracetam Teva is taken twice
daily, in two equally divided doses, each individual
dose being measured between 0.07 ml (7 mg) and
0.21 ml (21 mg), per kg bodyweight of the infant. (see
table below for dose examples).
Dose in infants (1 month to less than 6 months):
Weight Starting dose:
0.07 ml/kg twice
daily

Maximum dose:
0.21 ml/kg twice
daily

4 kg

0.3 ml twice daily

0.85 ml twice daily

5 kg

0.35 ml twice daily

1.05 ml twice daily

6 kg

0.45 ml twice daily

1.25 ml twice daily

7 kg

0.5 ml twice daily

1.5 ml twice daily

Method of administration:
After measuring the correct dose with an
appropriate syringe, Levetiracetam Teva oral solution
may be diluted in a glass of water or baby´s bottle.
You may take Levetriacetam with or without food.
Instructions for use:
• Open the bottle: press the cap and
turn it anticlockwise (figure 1).

• Insert the syringe adaptor into the
bottle neck (figure 2).
Ensure it is well fixed.
• Take the syringe and put it in
the adaptor opening (figure 2).

• Turn the bottle upside down
(figure 3).

Version 6.6

1

2

3

Approved

No
420 mm
154 mm
N/A
N/A

Colours Used:

• Fill the syringe with a small amount of solution by
pulling the piston down (figure 4), then push the
piston upward in order to remove any possible
bubbles (figure 5). Pull the piston down to the
graduation mark corresponding to the quantity in
millilitres (ml) prescribed by your doctor (figure 6).

Version:

5

23 June 2017
BLACK
PANTONE® GREEN C
Template

• vertigo (sensation of rotation)
• cough
• abdominal pain, diarrhoea, dyspepsia (indigestion),
vomiting, nausea
• rash
• asthenia/fatigue (tiredness).
Uncommon: may affect 1 to 10 users in 1000 people
• decreased number of blood platelets, decreased
number of white blood cells
• weight decrease, weight increase
• suicide attempt, mental disorder, abnormal
behaviour, hallucination, anger, confusion, panic
attack, agitation
4
5
6
• amnesia (loss of memory), memory impairment
• Turn the bottle the right way up.
(forgetfulness), abnormal coordination/ataxia
• Remove the syringe from the adaptor.
(impaired coordinated movements), paraesthesia
• Empty the contents of the syringe into
(tingling), disturbance in attention (loss of
a glass of water or baby’s bottle by
concentration)
pushing the piston to the bottom
• diplopia (double vision), vision blurred
(figure 7).
7 • elevated/abnormal values in a liver function test
• Drink the whole contents of the
• hair loss, eczema, pruritus
glass / baby´s bottle
• muscle weakness, myalgia (muscle pain)
• injury.
• Close the bottle with the plastic
screw cap.
Rare: may affect 1 to 10 users in 10,000 people
• Wash the syringe with water only
• infection
(figure 8).
• decreased number of all blood cell types
8 • severe allergic reactions (DRESS, anaphylactic
Duration of treatment:
reaction [severe and important allergic reaction],
Levetiracetam Teva is used as a chronic treatment.
Quincke’s oedema [swelling of the face, lips,
You should continue Levetiracetam Teva treatment
tongue and throat]);
for as long as your doctor has told you.
• suicide, personality disorders (behavioural
Do not stop your treatment without your doctor’s
problems), thinking abnormal (slow thinking,
advice as this could increase your seizures.
unable to concentrate)
If you take more Levetiracetam Teva than you should:
• uncontrollable muscle spasms affecting the head,
The possible side effects of an overdose of
torso and limbs, difficulty in controlling
Levetiracetam Teva are sleepiness, agitation,
movements, hyperkinesia (hyperactivity)
aggression, decrease of alertness, inhibition of
• liver failure ,hepatitis
breathing and coma.
• Sudden decrease in kidney function
Contact your doctor if you took more Levetiracetam
• Low blood levels of sodium which can cause
Teva than you should. Your doctor will establish the
tiredness and confusion, muscle twitching, fits or
best possible treatment for an overdose.
coma
If you forget to take Levetiracetam Teva:
• Rhabdomyolysis (breakdown of muscle tissue) and
Contact your doctor if you have missed one or more
associated blood creatine phosphokinase increase.
doses.
Prevalence is significantly higher in Japanese
Do not take a double dose to make up for a forgotten
patients when compared to non-Japanese patients.
dose.
Reporting of side effects
If you stop taking Levetiracetam Teva:
If you get any side effects, talk to your doctor or
Do not stop your treatment without your doctor’s
pharmacist. This includes any possible side effects
advice as this could increase your seizures.
not listed in this leaflet. You can also report side
If stopping treatment, Levetiracetam Teva should be effects directly via the Yellow Card Scheme at:
discontinued gradually to avoid an increase of
www.mhra.gov.uk/yellowcard.
seizures.
By reporting side effects you can help provide more
Should your doctor decide to stop your Levetiracetam information on the safety of this medicine.
Teva treatment, he/she will instruct you about the
gradual withdrawal of Levetiracetam Teva.
to store Levetiracetam Teva
5 How
100mg/ml Oral Solution
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated
Possible
side
effects
4
on the cardboard box and bottle after EXP. The expiry
Like all medicines, this medicine can cause side
date refers to the last day of the month. Do not use
effects, although not everybody gets them.
after 7 months of first opening the bottle.
You should go to Accident and Emergency
Due to sensitivity to light, store in the original container.
immediately if you experience symptoms of;
Store in an upright position.
• weakness, feel light-headed or dizzy or have
Do not thorw away any medicines via wastewater or
difficulty breathing, as these may be signs of a
household waste. Ask your pharmacist how to throw
serious allergic (anaphylactic) reaction
away medicines you no longer use. These measures
• swelling of the face, lips, tongue and throat
will help to protect the environment.
(Quincke’s oedema)
• flu-like symptoms and a rash on the face followed
6 Contents of the pack and other information
by an extended rash with a high temperature,
What Levetiracetam Teva 100 mg/ml oral solution
increased levels of liver enzymes seen in blood
contains
tests and an increase in a type of white blood cell
The active substance is levetiracetam. Each ml
(eosinophilia) and enlarged lymph nodes (Drug
contains 100 mg of levetiracetam.
Reaction with Eosinophilia and Systemic
The other ingredients are:
Symptoms [DRESS]).
Sodium citrate, Citric acid monohydrate, Methyl
• symptoms such as low urine volume, tiredness,
parahydroxybenzoate (E218), Propyl
nausea, vomiting, confusion and swelling in the
parahydroxybenzoate (E216), Ammonium
legs, ankles or feet, as this may be a sign of
glycyrrhizate, Glycerol (E422), Maltitol liquid (E965),
sudden decrease of kidney function
Acesulfame potassium (E950), Grapefruit flavour,
• a skin rash which may form blisters and look like
small targets (central dark spots surrounded by a Purified water.
What Levetiracetam Teva 100 mg/ml oral solution
paler area, with a dark ring around the edge)
looks like and contents of the pack
(erythema multiforme)
• a widespread rash with blisters and peeling skin, Levetiracetam Teva 100 mg/ml oral solution is a clear
particularly around the mouth, nose, eyes and
liquid.
genitals (Stevens-Johnson syndrome)
50 ml solution (sample pack) in an amber glass bottle
• a more severe form of rash causing skin peeling in with a white child resistant closure in a cardboard
more than 30% of the body surface (toxic
box also containing a 1 ml oral syringe (graduated
epidermal necrolysis)
every 0.05 ml) and an adaptor for the syringe.
• signs of serious mental changes or if someone
around you notices signs of confusion, somnolence 150 ml solution in an amber glass bottle with a white
child resistant closure (for infants aged 1 month to
(sleepiness), amnesia (loss of memory), memory
impairment (forgetfulness), abnormal behaviour or less than 6 months) in a cardboard box also
containing a 1 ml oral syringe (graduated every
other neurological signs including involuntary or
0.05 ml) and an adaptor for the syringe.
uncontrolled movements). These could be
150 ml solution in an amber glass bottle with a white
symptoms of an encephalopathy.
child resistant closure (for infants and young children
You should contact your doctor immediately if you
aged from 6 months to less than 4 years) in a cardboard
experience symptoms of severe abdominal and back box also containing a 3 ml oral syringe (graduated every
pain accompanied with feeling very unwell
0.1 ml) and an adaptor for the syringe.
(pancreatitis) or hepatic failure.
300 ml solution in an amber glass bottle with a white
You should see your doctor immediately if you
child resistant closure (for children aged 4 years and
experience depression, emotional instability/mood
above, adolescents and adults) in a cardboard box
swings, or suicidal thoughts or behaviour.
also containing a 10 ml oral syringe (graduated every
Some of the side effects like sleepiness, tiredness
0.25 ml) and an adaptor for the syringe.
and dizziness may be more common at the beginning Not all pack sizes may be marketed.
of the treatment or at dose increase. These effects
Marketing Authorisation Holder and Manufacturer
should however decrease over time.
Marketing Authorisation Holder
Very common: may affect more than 1 in 10 people
Teva UK Limited, Eastbourne, BN22 9AG, United
• nasopharyngitis (cough, sore throat, runny nose
Kingdom
and fever)
Manufacturer
• somnolence (sleepiness); headache.
Bluepharma Indústria Farmacêutica, S.A,
Common: may affect up to 1 to 10 users in 100 people S. Martinho de Bispo, 3045-016 Coimbra, Portugal
• anorexia (loss of appetite)
This leaflet was last revised in 06/2017
• hostility or aggression, anxiety, insomnia,
PL 00289/1703
nervousness or irritability
• convulsion, balance disorder (equilibrium
disorder), dizziness (sensation of unsteadiness),
lethargy (lack of energy and enthusiasm), tremor
EBNUK1439b
(involuntary trembling)
154 x 420

Page 1 of 2

THIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE

Teva Pharmaceuticals Europe B.V
1.3.2 mockup-pil-uk-pl-00289-1703-levetiracetam-100-mg-ml-oral-solution

APPROVALS
Signed by
Michael Silvester

REG0093670

Meaning of Signature
Regulatory Affairs Approval

Version 6.6

Approved

Server Date
29-Jun-2017 11:53:49 AM

Page 2 of 2

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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